MINIRIN Oral Lyophilisate 60 mcg

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

Desmopressin acetate 67mcg eqv to Desmopressin

Доступна с:

FERRING PHARMACEUTICALS PRIVATE LIMITED

код АТС:

H01BA02

дозировка:

60 mcg

Фармацевтическая форма:

TABLET, ORALLY DISINTEGRATING

состав:

Desmopressin acetate 67mcg eqv to Desmopressin 60 mcg

Администрация маршрут:

SUBLINGUAL

Тип рецепта:

Prescription Only

Производитель:

Catalent U.K. Swindon Zydis Limited

Статус Авторизация:

ACTIVE

Дата Авторизация:

2012-10-30

тонкая брошюра

MINIRIN
®

ORAL LYOPHILISATES 60 
ΜG AND 120 ΜG 
NAME AND STRENGTH OF ACTIVE SUBSTANCE 
MINIRIN
®  
oral lyophilisate 60 
μg:   
Each unit contains 60 μg desmopressin (free base), added as
desmopressin acetate. 

MINIRIN
®  
oral lyophilisate 120 
μg:   
Each unit contains 
120 μg desmopressin (free base), added as desmopressin acetate. 

Excipients: Gelatin, mannitol (E421) and citric
acid (anhydrous). 

PHARMACEUTICAL FORM 
MINIRIN
®  
oral lyophilisate 
60 μg: White, round, oral lyophilisate marked with a drop shaped figure on one side. 
MINIRIN
®  
oral lyophilisate 
120 μg: White, round, oral
lyophilisate marked with two drop shaped figures on one side. 

THERAPEUTIC INDICATIONS 
MINIRIN
®
 oral lyophilisate is
indicated for the treatment of central diabetes insipidus.   
MINIRIN
®
 oral lyophilisate is
indicated for the treatment of primary nocturnal enuresis
in patients (from 5 years of age) with normal ability to concentrate urine. 

POSOLOGY AND METHOD OF ADMINISTRATION 
General 
Method of administration: MINIRIN
®
 oral
lyophilisate is placed under the tongue where it dissolves without the need for water. 
In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be 
interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see section Special warnings and precautions
for use). 
If adequate clinical effect is not achieved within 4 weeks
following appropriate dose titration the medication should be discontinued. 

Indication specific 
_Central diabetes insipidus: _
Dosage is individual in diabetes insipidus
but the total daily sublingual dose normally lies in the range of

Характеристики продукта

MINIRIN
®
ORAL LYOPHILISATES 60 ΜG, 120 ΜG AND 240UG
NAME AND STRENGTH OF ACTIVE SUBSTANCE
MINIRIN
®
oral lyophilisate 60 μg:
Each unit contains 60 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
oral lyophilisate 120 μg:
Each unit contains 120 μg desmopressin (free base), added as
desmopressin acetate.
MINIRIN
®
oral lyophilisate 240 μg:
Each unit contains 240 μg desmopressin (free base), added as
desmopressin acetate.
Excipients: Gelatin, mannitol (E421) and citric acid (anhydrous).
PHARMACEUTICAL FORM
MINIRIN
®
oral lyophilisate 60 μg: White, round, oral lyophilisate marked with
a drop shaped figure on one side.
MINIRIN
®
oral lyophilisate 120 μg: White, round, oral lyophilisate marked with
two drop shaped figures on one side.
MINIRIN
®
oral lyophilisate 240 μg: White, round, oral lyophilisate marked with
three drop shaped figures on one side.
THERAPEUTIC INDICATIONS
MINIRIN
®
oral lyophilisate is indicated for the treatment of central diabetes
insipidus.
MINIRIN
®
oral lyophilisate is indicated for the treatment of primary nocturnal
enuresis in patients (from 5 years of age) with normal ability to
concentrate urine.
POSOLOGY AND METHOD OF ADMINISTRATION
General
Method of administration: MINIRIN
®
oral lyophilisate is placed under the tongue where it dissolves
without the need for water.
In the event of signs or symptoms of water retention and/or
hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe
cases, convulsions) treatment should be
interrupted until the patient has fully recovered. When restarting
treatment strict fluid restriction should be enforced (see section
Special warnings and precautions for use).
If adequate clinical effect is not achieved within 4 weeks following
appropriate dose titration the medication should be discontinued.
Indication specific
_Central diabetes insipidus: _
Dosage is individual in diabetes insipidus but the total daily
sublingual dose normally lies in the range of 120 μg to 720 μg. A
suitable starting dose in adu